By Diagnostics World Staff
April 30, 2020 | Yesterday, the National Institutes of Health announced a new initiative aimed at speeding innovation, development, and commercialization of COVID-19 testing technologies. The Rapid Acceleration of Diagnostics (RADx) initiative—fueled by $1.5 billion from the federal stimulus funding—is meant to infuse funding into early innovative technologies to speed development of rapid and widely accessible COVID-19 testing. NIH is urging all scientists and inventors with a rapid testing technology to participate.
RADx will support novel solutions that build the U.S. capacity for SARS-CoV-2 testing up to 100-fold above what is achievable with standard approaches, making millions of accurate and easy-to-use tests available to all Americans by the end of summer 2020, and even more in time for the flu season.
“If all goes well, RADx aims to support innovative technologies that will make millions more rapid SARS-CoV-2 tests available to Americans by late summer or fall,” wrote NIH Director Francis S. Collins in his NIH Director’s Blog. “Such widespread testing, which will facilitate the speedy identification and quarantine of infected individuals and their contacts, will likely be a critical component of making it possible for Americans to get safely back into public spaces, including returning to work and school.”
RADx is enlisting the oversight of the Point-of-Care Technologies Research Network (POCTRN), a network established several years ago by NIBIB. POCTRN supports hundreds of investigators from multiple universities and businesses through technology hubs at Emory University/Georgia Institute of Technology, Atlanta; Johns Hopkins University, Baltimore; Northwestern University, Evanston, Illinois; University of Massachusetts Medical School, Worcester; and the Consortia for Improving Medicine with Innovation & Technology (CIMIT) at Harvard Medical School/Massachusetts General Hospital, Boston.
Led by the Coordinating Center at CIMIT, POCTRN has assembled expert review boards covering scientific, clinical, regulatory, and business domains that will rapidly evaluate RADx technology proposals.
COVID-19 Shark Tank
In his blog, Collins compares the first step of the RADx program to the television pitch show, Shark Tank. Project proposals can be submitted now through the online RADx portal. All proposals will be reviewed within a week of receipt by an external panel of experts for technical, clinical, regulatory, and commercialization feasibility—the Shark Tank portion of the challenge.
Those invited to progress in the competition will be immediately assigned a team of healthcare commercialization and content experts to develop the work package with the applicants, which could take from a few days to two weeks.
Once the work package is developed, phase 1 begins and is meant to address high-risk barriers to success. Phase 1 is generally expected to last about four weeks, and achieving milestones here launches Phase 2. Phase 2 will cover the full range of activities needed to distribute a viable product to the public.
If certain selected technologies are already relatively far along in development, they can immediately advance to the appropriate step in the commercialization process.
Along the way, reasonable funds will be provided to the awardee to cover costs at each stage. For projects entering Phase 2, budgets of tens of millions of dollars are anticipated, and will include funding for scale-up and manufacturing to enable large-scale distribution by late summer 2020 or as early as feasible for the proposed solution. NIH will supply the needed budget, partnerships and other resources to fully deploy successful tests to the public on the shortest possible timeline. NIH will negotiate cost sharing with for-profit institutions as appropriate.
Tests will be evaluated on their technical, clinical, commercial, and regulatory strengths.
Can the technology be developed to the highest levels of analytical performance? Is the design patient- and user-friendly? Can it use alternative sampling strategies (saliva, exhaled breath, etc.)? Do these technical/design advances reduce barriers to expanding national testing capacity and provide clear advantages over current approaches? Does the proposal provide a realistic approach to increasing SARS-CoV-2 testing in a way that can be rapidly integrated into and adopted by the healthcare system? Can it be manufactured at scale in an economically viable way? Finally, are there feasible plans to perform the studies required to obtain FDA Emergency Use Authorization (EUA) and to subsequently obtain FDA clearance?
A War-Era Challenge
The RADx acronym recalls MIT’s “Rad Lab”, or radiation laboratory, that worked on radar during World War II era, allowing us to “see” planes, storm systems, and other things crucial to the war effort.
“As for NIH’s RADx,” Collins writes in his blog, “our aim is to speed the development and commercialization of tests that can rapidly “see” if people have been infected with SARS-CoV-2 with very high sensitivity and specificity, meaning there would be few false negatives and false positives.”
He closes his blog with a challenge: “So, to the U.S. science and engineering community, I have these words: Let’s get going—our nation has never needed your skills more!”